The Cytel Blog: Perspectives on Enquiry & Evidence

I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual..

Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation..

In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after..

Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our..

Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC..

The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..

Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance..

For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification..

I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..